A multicenter randomized controlled clinical study of pazufloxacin versus levofloxacin in the treatment of acute urinary tract infections

Huang Yi-ra

Zhongguo kangganran hualiao zazhi, 2006

Abstract

ObjectiveTo evaluate the clinical efficacy and safety of domestic injectable pazufloxacin for the treatment of moderate and severe acute bacterial urinary tract infections.MethodsA multicenter randomized controlled clinical study was conducted to compare the efficacy and safety of pazufloxacin with levofloxacin.Pazufloxacin and levofloxacin were administered intravenously at the dose of 300 mg and 200 mg twice daily for 7 to 10 days respectively.ResultsOne hundred and seventeen(117) patients were enrolled in the study,58 in pazufloxacin group and 59 in levofloxacin group.Only 1 patient withdrew from pazufloxacin group due to bacterial resistance.In general,57 cases in pazufloxacin group and 59 in levofloxacin group were assessable for clinical efficacy by full analysis set(FAS) analysis and per-protocol set(PPS) analysis.At the end of the treatment,the total cure rates and effective rates were 71.9% and 93.0% in pazufloxacin group,and 67.8% and 83.1% in levofloxacin group respectively.The bacterial eradication rates were 97.6% and 93.8% respectively.There were no statistically significant differences between the two groups.Adverse reactions were observed in 12.1% and 15.3% of patients in the two groups,mainly nausea,diarrhea,dizziness,local stimulation and elevated transaminases.No serious adverse event was reported in any group.ConclusionsDomestic injectable pazufloxacin is as effective and safe as levofloxacin in the treatment of moderate and severe acute bacterial…

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